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Rituximab-induced Pulmonary Function Changes

NCT ID: NCT01632124

Last Updated: 2012-06-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-12-31

Brief Summary

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Measuring lung function (FVC, FEV1, DLCO) before, during and after treatment with rituximab in patients with rheumatoid arthritis or inflammatory myositis.

Detailed Description

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The objective of this study is to investigate whether rituximab (RTX), a drug commonly prescribed in patients with rheumatoid arthritis (RA) or inflammatory myositis, is associated with subclinical interstitial lung disease (ILD). Surrogate markers for interstitial lung diseases are a decrease of the forced vital capacity (FVC) and/or the diffusing capacity of the lung for carbon monoxide (DLCO). However, the measurement of these lung function parameters is indicated as regular follow-up examinations during the treatment with RTX according to the principles of "good clinical practice". We will perform pulmonary function testing (spirometry) including measurement of the DLCO in patients with RA, who are going to be treated with RTX. A baseline lung function measurement will be performed immediately before RTX therapy is started. Follow-up measurements will be performed at 2 weeks, 4 weeks, 8 weeks and 6 months after initiation of RTX therapy. A reduction in forced vital capacity (FVC) of \>10% or a fall of \>15% in DLCO will be defined as indicative for ILD.

Conditions

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Rheumatoid Arthritis Inflammatory Myositis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Lung function measurement

Spirometry and measurement of diffusing capacity for carbon monoxide

Intervention Type OTHER

Other Intervention Names

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Spirometry CO diffusing capacity

Eligibility Criteria

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Inclusion Criteria

* Age \>18 y
* Informed consent of patient

Exclusion Criteria

* Pre-existing interstitial pulmonary disease
* Patients with impaired forced vital capacity (FVC) on spirometry (\<80% predicted) or with impaired DLCO (\<75% predicted).
* Pregnancy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Daniel Franzen, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Zurich, Division of Internal Medicine

Locations

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University Hospital Zurich, Division of Internal Medicine

Zurich, Canton of Zurich, Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Daniel Franzen, MD

Role: CONTACT

Email: [email protected]

Other Identifiers

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RTX

Identifier Type: -

Identifier Source: org_study_id